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Recall Observatory FDA recall evidence

Device product

VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

Z-1834-2020

March 10, 2020

Class III

Product summary

Firm
Ortho Clinical Diagnostics
Event
Event 85298
Status
Terminated
Classification
Class III
Quantity
3181
Official record key
device-enforcement:Z-1834-2020

Official wording

Reason: The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

Code information: UDI: 10758750005147; Lot Number: 2340

Distribution pattern: US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.